Real-World Evidence Likely Untainted By COVID-19 Journal Article Debacle
Retraction of Lancet, NEJM studies does not signal doubts about the utility of RWE for evaluating drug efficacy and safety; instead, it highlights importance of transparency, validation and audit trails for real-world datasets, and lack of familiarity with RWE methods among medical journal peer reviewers, experts say.
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Speedy publication and data validation methods were red flags in studies retracted by Lancet and NEJM, IQIVA’s Nancy Dreyer says. Duke-Margolis and Sanofi researchers note growth in use of real-world evidence in drug applications at DIA’s annual meeting.
Coronavirus Notebook: Fauci Calls For Restraint In Disclosing Early Data; Bipartisan Lawmakers Want Warp Speed Audit
Dispatches from a world turned upside down also include the conditional approval of remdesivir in South Korea.
Coronavirus Notebook: Remdesivir Supply Dwindles; US FDA Signs Another RWE Deal; Corning Gets BARDA Contract For Glass Vials
Dispatches from a world turned upside down also include changes in drug sample distribution guidelines and further reductions in the hours of FDA’s COVID hotline.